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Trial registered on ANZCTR


Registration number
ACTRN12616001643460
Ethics application status
Approved
Date submitted
2/09/2015
Date registered
28/11/2016
Date last updated
28/11/2019
Date data sharing statement initially provided
28/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Non-invasive medical device for the treatment of chronic constipation: 1. Proof of Principle study in children.
Scientific title
In children aged 4-18 years with chronic constipation, what is the effect of a new transcutaneous electrical stimulation device (rhythm.IC, GI Therapies) on defecation frequency and constipation symptoms?
Secondary ID [1] 287400 0
nil
Universal Trial Number (UTN)
U1111-1173-9182
Trial acronym
rhythmIC PoP Child
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Constipation 296106 0
Condition category
Condition code
Oral and Gastrointestinal 296362 296362 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transcutaneous Electrical Stimulation (TES) will be delivered from the rhythm.IC device, GI Therapies, Melbourne.
electrical stimulation will be applied using sticky electrodes on the skin. Electrodes are applied for the period of stimulation only. There will be four electrodes applied on abdomen and another four on the lower back, held in place by a specially designed belt which also holds the small battery-powered stimulator used to control and deliver the current. The current is first applied at the lowest frequency and increased within the specified limits until tingling is felt and then raised until it becomes uncomfortable. The current intensity is then turned down to a comfortable level. This is set as the treatment level and is stored in the device memory. The device automatically ramps up to this level at a comfortable rate when turned on. .
Stimulation will be applied at home for 60 min/day for 4 to 8 months.
Current will be delivered via two channels, one at 4000 Hz and the other at 4080 to 4160 Hz to create a beat frequency of 80-160 Hz,
Current will be delivered at the highest comfortable level for the patient (maximum intensity 40mA).
The device records usage (time used in minutes and highest level used and date) and a report can be generated by the clinician showing a calendar with minutes used and highest level each day.
Intervention code [1] 292754 0
Treatment: Devices
Comparator / control treatment
Baseline data measured for 2 weeks before electrical stimulation commences
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296011 0
Change in constipation symptom severity score (using the Wexner constipation scoring system. Constipation consists of a number of symptoms. The Wexner constipation scoring system measures 6 items using a value of 0 to 4 for each item (total score 24, higher score is worse constipation).
Timepoint [1] 296011 0
at baseline and after 2 months stimulation.
Secondary outcome [1] 319452 0
Defaecation frequency,- estimated by patient and recorded in daily stool diary
Timepoint [1] 319452 0
Measured daily using diary for 2 weeks at baseline, for 4 to 8 months stimulation and for 2 weeks after 3 months without stimulation.
Secondary outcome [2] 319453 0
Defaecation volume,- estimated by patient and recorded in daily stool diary
Timepoint [2] 319453 0
Measured daily using diary for 2 weeks at baseline, for 4 to 8 months stimulation and for 2 weeks after 3 months without stimulation.
Secondary outcome [3] 319454 0
Defaecation consistency - estimated by patient using the Bristol Stool Scale and recorded in daily stool diary
Timepoint [3] 319454 0
Measured daily using diary for 2 weeks at baseline, for 4 to 8 months stimulation and for 2 weeks after 3 months without stimulation.
Secondary outcome [4] 319455 0
Frequency of straining during defecation- estimated by patient and recorded in daily stool diary
Timepoint [4] 319455 0
Measured daily using diary for 2 weeks at baseline, for 4 to 8 months stimulation and for 2 weeks after 3 months without stimulation.
Secondary outcome [5] 319456 0
Feeling of incomplete evacuation- recorded in daily stool diary
Timepoint [5] 319456 0
Measured daily using diary for 2 weeks at baseline, for 4 to 8 months stimulation and for 2 weeks after 3 months without stimulation.
Secondary outcome [6] 319457 0
Abdominal pain- recorded in daily stool diary, using scale 0= never to 4 = always
Timepoint [6] 319457 0
Measured daily using diary for 2 weeks at baseline, for 4 to 8 months stimulation and for 2 weeks after 3 months without stimulation.
Secondary outcome [7] 319458 0
Bloating- recorded in daily stool diary using VAS scale 0 to 4, never to always
Timepoint [7] 319458 0
Measured daily using diary for 2 weeks at baseline, for 4 to 8 months stimulation and for 2 weeks after 3 months without stimulation.
Secondary outcome [8] 319459 0
Effect on daily activities. Patient/parent are asked if their constipation affects their daily activities. binary yes/no
Timepoint [8] 319459 0
Measured daily using diary for 2 weeks at baseline, for 4 to 8 months stimulation and for 2 weeks after 3 months without stimulation.
Secondary outcome [9] 319460 0
Laxative use- recorded in daily stool diary
Timepoint [9] 319460 0
Measured daily using diary for 2 weeks at baseline, for 4 to 8 months stimulation and for 2 weeks after 3 months without stimulation.
Secondary outcome [10] 319461 0
Quality of life (QOL) - questionnaires from PedsQL suite (Core, gastrointestinal scores and family functioning)
Timepoint [10] 319461 0
Measured daily using diary for 2 weeks at baseline, for 4 to 8 months stimulation and for 2 weeks after 3 months without stimulation.
Secondary outcome [11] 319462 0
Ease/difficulty of use of device and instructions. Patient/parent is asked about use of the device and instructions- is it easy or difficult.
Timepoint [11] 319462 0
after 4 months stimulation
Secondary outcome [12] 319463 0
change in constipation symptom severity score (Wexner constipation scoring system) at two further time points
Timepoint [12] 319463 0
After 4, 6, and 8 months stimulation and a further 3 months without stimulation.

Eligibility
Key inclusion criteria
Patients aged between 4 and 18 with chronic functional idiopathic constipation as defined by a > 6 month history of:
*Less than or equal to two “spontaneous complete bowel movement” (SCBM)/week for at least 6 months prior to recruitment and
*At least 25% of the time suffer from at least one symptom of: lumpy/hard stools, sensation of incomplete evacuation, need to strain during defaecation, or sensation of anorectal obstruction/blockage.
Minimum age
4 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Constipation secondary to endocrine causes, metabolic causes or neurological conditions
*Known or suspected organic disorders of the large bowel
*Serious chronic medical condition
*Surgical procedure on the large bowel or rectum
*Pregnancy or planning to become pregnant
*Insufficient comprehension of English requiring a translator
*Implanted cardiac defibrillator or pacemaker

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Phase II, Proof of principal study on small group.

descriptive statistics

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
12/12/2016
Actual
1/02/2017
Date of last participant enrolment
Anticipated
31/10/2018
Actual
30/08/2018
Date of last data collection
Anticipated
24/12/2019
Actual
Sample size
Target
40
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4298 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 10235 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 291966 0
Commercial sector/Industry
Name [1] 291966 0
GI therapies Pty Ltd
Country [1] 291966 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
GI therapies Pty Ltd
Address
Level 9, 31 Queen Street
Melbourne, VIC, 3000
Country
Australia
Secondary sponsor category [1] 290635 0
None
Name [1] 290635 0
Address [1] 290635 0
Country [1] 290635 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293463 0
Royal Childrens Hospital Human Research and Ethics Committee
Ethics committee address [1] 293463 0
Royal Children's Hospital
Royal Parade
Parkville
Victoria
Australia
3052
note no street number required-the hospital is a landmark in a small suburb.
Ethics committee country [1] 293463 0
Australia
Date submitted for ethics approval [1] 293463 0
07/09/2015
Approval date [1] 293463 0
07/12/2016
Ethics approval number [1] 293463 0
HREC/15/RCHM/85

Summary
Brief summary
This study aims to determine proof-of-principle if a new medical device (rhythm.IC, GI Therapies) is able to improve symptoms of chronic constipation in children. the device delivers painless electrical stimulation across the skin.

The new device has been designed using existing devices with additional safety features and better ease of use. The device has not yet been tested on patients.

The study does not aim to measure overall effectiveness, but to determine if the new device is able to improve symptoms of chronic constipation in some patients.

The primary objective is to determine if stimulation with rhythm.IC can improve constipation symptoms measured with a global measure (Wexner constipation scoring system) after 2 months stimulation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60026 0
Dr Bridget Southwell
Address 60026 0
Murdoch Childrens Research Institute
Level 5,
Royal Children's Hospital,
Flemington Road
Parkville
Victoria
Australia
3052
Country 60026 0
Australia
Phone 60026 0
+61 3 9345 5069
Fax 60026 0
Email 60026 0
[email protected]
Contact person for public queries
Name 60027 0
Bridget Southwell
Address 60027 0
Murdoch Childrens Research Institute
Level 5,
Royal Children's Hospital,
Flemington Road
Parkville
Victoria
Australia
3052
Country 60027 0
Australia
Phone 60027 0
+61 3 9345 5069
Fax 60027 0
Email 60027 0
[email protected]
Contact person for scientific queries
Name 60028 0
Bridget Southwell
Address 60028 0
Murdoch Childrens Research Institute
Level 5,
Royal Children's Hospital,
Flemington Road
Parkville
Victoria
Australia
3052
Country 60028 0
Australia
Phone 60028 0
+61 3 9345 5069
Fax 60028 0
Email 60028 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Trial is commercial in confidence.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.